Status:
COMPLETED
Sequential Treatment of Pediatric MDD to Increase Remission and Prevent Relapse
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
8-17 years
Phase:
NA
Brief Summary
This study will compare the effectiveness of fluoxetine alone with the effectiveness of fluoxetine with cognitive behavioral therapy in increasing recovery and preventing relapse in youth with major d...
Detailed Description
Major depressive disorder (MDD) is a serious psychiatric disorder that affects approximately 1 out of every 12 to 15 children and adolescents. Depression can cause problems with school, family, and fr...
Eligibility Criteria
Inclusion
- Primary diagnosis of nonpsychotic MDD (single or recurrent) for at least 4 weeks before study entry
- In good general medical health
- Normal intelligence
Exclusion
- Lifetime history of any psychotic disorder, including psychotic depression
- Lifetime history of bipolar I and II disorders
- Alcohol or substance dependence within the 6 months before study entry
- Anorexia nervosa or bulimia within the 6 months before study entry
- Pregnant or breastfeeding females, or sexually active females not using medically acceptable means of birth control (e.g., IUD, birth control pills, barrier devices)
- Chronic medical illness (medically unstable and requires regular medication that may interfere with treatment interventions)
- Concurrent medication(s) with psychotropic effects (e.g., anticonvulsants, steroids, etc.) other than stable ADHD medication
- First degree relatives with bipolar I disorder
- Severe suicidal ideation or previous history of serious suicide attempt within this episode
- Prior failure to respond to an adequate treatment with fluoxetine (defined as at least 40 mg/day for 4 weeks)
- Non-English speaking
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00612313
Start Date
February 1 2008
End Date
January 1 2014
Last Update
January 7 2016
Active Locations (1)
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1
Children's Medical Center of Dallas, Outpatient Psychiatry Clinic
Dallas, Texas, United States, 75235